510(k) · Cleared
ClearedTRC-Pex, Radic-Sealer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Km Corporation · KIF Resin, Root Canal Filling
Cleared on Mar 20, 2014 as substantially equivalent to K032603 (Meta Biomed Co., Ltd., 2003) and 2 other predicates after a 253-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Mar 20, 2014
- Review
- 253 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K960548 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK960548 AH Plus Root Canal SealerDentsply Intl. · 1996
- 2 generations backK992727 The BI-Directional Spiral & Epoxy Root Canal Cement SystemMds · 2000
- 1 generation backK042769 Adseal Root Canal SealerMeta Biomed Co., Ltd. · 2004
- This deviceK132123 TRC-Pex, Radic-SealerKm Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960548 | AH Plus Root Canal Sealer | Dentsply Intl. | 1996 | — |
| −2 | K992727 | The BI-Directional Spiral & Epoxy Root Canal Cement System | Mds | 2000 | — |
| −1 | K042769 | Adseal Root Canal Sealer | Meta Biomed Co., Ltd. | 2004 | — |
| 0 (this device) | K132123 | TRC-Pex, Radic-Sealer | Km Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KIF device
- #1 K250710 Injectable Root Canal Bioceramic Sealer (nRoot…score 14.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032603 | Metapex Calcium Hydroxide with Lodoform Temporary Root Canal FillingSummary page 2…Class 11, 21 CFR 872.3820 Classification Product Code: KIF KM Corporation 4. Predicate Device: Metapex by Meta Dental Co. (K032603) Adlseal by Meta Dental Co. (K042769) AH Plus by Dentsply DeTrey GmbH- (K960548) 5. Device Description:… | 2003 |
| * | K042769 | Adseal Root Canal SealerSummary page 2…ssification Product Code: KIF KM Corporation 4. Predicate Device: Metapex by Meta Dental Co. (K032603) Adlseal by Meta Dental Co. (K042769) AH Plus by Dentsply DeTrey GmbH- (K960548) 5. Device Description: TRC-Pex TRC-Pex is an immediately… | 2004 |
| * | K960548 | AH Plus Root Canal SealerSummary page 2…= KM Corporation 4. Predicate Device: Metapex by Meta Dental Co. (K032603) Adlseal by Meta Dental Co. (K042769) AH Plus by Dentsply DeTrey GmbH- (K960548) 5. Device Description: TRC-Pex TRC-Pex is an immediately available pre-mixed root canal filling material b… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K032603.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KIF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KIF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KIF
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIF
55in 2025
MAUDE reports naming product code KIF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 4 | 31 | 0 | 2 |
| 2009 | 5 | 94 | 1 | 7 |
| 2010 | 5 | 75 | 0 | 10 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 5 | 172 | 0 | 4 |
| 2013 | 2 | — | 0 | 79 |
| 2014 | 10 | 220 | 0 | 421 |
| 2015 | 1 | — | 0 | 15 |
| 2016 | 5 | 212 | 0 | 5 |
| 2017 | 3 | 211 | 0 | 5 |
| 2018 | 5 | 147 | 0 | 13 |
| 2019 | 7 | 252 | 0 | 6 |
| 2020 | 3 | 239 | 0 | 3 |
| 2021 | 12 | 89 | 0 | 9 |
| 2022 | 3 | 152 | 0 | 10 |
| 2023 | 7 | 59 | 0 | 7 |
| 2024 | 8 | 96 | 0 | 10 |
| 2025 | 7 | 90 | 0 | 55 |
| 2026 | 7 | 108 | 0 | — |
What is it indicated for?
The TRC-Pex is a temiporary root canal sealer for use in the treatment of root canals, following a pulpeclomy or for apexegenesis or apexification.
The Radic-Sealer is a root canal sealer for permanent sealing of root canals following established endlodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). The Radic-Sealer is intended for use by qualified healthcare personnel trained in its use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132123 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132123: TRC-Pex, Radic-Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132123
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026